Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor 1

Filing based on four Phase 3 studies that met all primary and co-primary endpoints. This unprecedented data package includes head-to-head superiority comparisons versus deucravacitinib, adolescent data, and evaluation of difficult to treat skin sites2,3,4,5,6

Submission underscores that icotrokinra has the potential to offer moderate-to-severe plaque psoriasis patients the combination of complete skin clearance and a favourable safety profile, relative to comparators, with the simplicity of a once-daily tablet. 2,3,4,5,6

NEWARK, CA / ACCESS Newswire / September 11, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced the submission of an application to the European Medicines Agency (EMA) by Johnson & Johnson seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe plaque psoriasis (PsO).1Icotrokinra is an investigational targeted oral tablet that is designed to block the IL-23 receptor,which underpins the inflammatory response in PsO and offers potential in other IL-23-mediated diseases.7,8

The application included data from four Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb, and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and adolescents 12 years of age and older with moderate-to-severe PsO, demonstrating significant skin clearance and a favourable safety profile in a once-daily tablet, as previously established in the ICONIC-LEAD and ICONIC-TOTAL clinical studies. 2,3,4,5,6 Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe PsO.d,e,5,6 Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.2,3,4,5,6